Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00068432
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of pancreatic cancer by stopping blood flow to the tumor and blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with celecoxib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with celecoxib works in treating patients with metastatic pancreatic cancer.
- Detailed Description
OBJECTIVES:
* Determine the overall survival at 6 months in patients with metastatic pancreatic cancer treated with gemcitabine and celecoxib.
* Determine the objective tumor response, progression-free survival, and median survival of patients treated with this regimen.
* Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive gemcitabine IV over 65 minutes on days 1, 8, and 15 and oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 6 months from study entry and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 8 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemcitabine + Celecoxib Celecoxib Oral celecoxib twice daily on days 1-28. Gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks. Gemcitabine + Celecoxib Gemcitabine Hydrochloride Oral celecoxib twice daily on days 1-28. Gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.
- Primary Outcome Measures
Name Time Method Overall Survival at 6 months 6 Months
- Secondary Outcome Measures
Name Time Method Overall response rate 6 months
Trial Locations
- Locations (11)
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
🇺🇸Fort Smith, Arkansas, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
M.D. Anderson Cancer Center - Orlando
🇺🇸Orlando, Florida, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
All Saints Cancer Center at All Saints Healthcare
🇺🇸Racine, Wisconsin, United States